The following data is part of a premarket notification filed by Femmepharma Consumer Healthcare, Llc with the FDA for Satisfaite.
Device ID | K190752 |
510k Number | K190752 |
Device Name: | Satisfaite |
Classification | Lubricant, Personal |
Applicant | FemmePharma Consumer Healthcare, LLC 175 Strafford Ave., Bldg 4, Suite 275 Wayne, PA 19087 |
Contact | Gerianne Dipiano |
Correspondent | Stuart R. Goldman Emergo By UL 2500 Bee Cave Road; Bldg. 1, Suite 300 Austin, TX 78746 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-25 |
Decision Date | 2019-12-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860000221511 | K190752 | 000 |
00850035529003 | K190752 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SATISFAITE 88545628 not registered Live/Pending |
FemmePharma Consumer Healthcare, LLC 2019-07-29 |